Dear Owen Bowden-Jones
I am writing on behalf of Drug Science in relation to the ACMD update report on medical cannabis last November. The Drug Science Medical Cannabis Working Group (MCWG) has now had time to discuss your report and I wanted to give you our feedback.
First, we endorse your recommendation of a national database of patients with medical cannabis prescriptions and would like to introduce you to one we have set up as part of our TWENTY21 initiative – see https://www.drugscience.org.uk/project-twenty21/. This uses well-proven and easy-to-use electronic data capture software that allows clinicians to enter data on diagnosis, medical history, medical cannabis prescriptions and clinical outcomes. So far, we have over 25 clinicians using it and over 600 patients entered; this number is expected to grow to many thousand in 2021. The first academic paper on TWENTY21 is currently under review in the journal Psychopharmacology.
As we are in discussions with NHS England over giving them free access to the database and outcome data, I thought the ACMD should also be informed about it. We would be happy to make a presentation at one of your meetings.
Secondly, we have conducted an audit of clinical outcomes in ten of the children and young people with epilepsy who are part of the End Our Pain group. This has revealed that full spectrum medical cannabis products from Bedrocan Holland have significantly reduced seizure frequency in all ten patients, some becoming completely seizure-free (see https://journals.sagepub.com/doi/full/10.1177/2050324520974487 ). Overall, we found a remarkable, on average, 80% reduction in seizure frequency. We believe this is convincing proof of the improved efficacy of this form of medical cannabis, compared with extract products such as Sativex and Epidyolex.
In the process of developing the TWENTY21 project and the epilepsy audit we have come across a number of issues that hamper clinical use and research with medical cannabis that the ACMD could help improve. These are
- Their Schedule 2 status, which adds complexity to prescribing, storage and importation. Schedules relate to the relative safety of medicines and define safe-keeping and prescribing regulations. Decisions on the correct Schedule for any medicine should therefore reflect risk of harm from inappropriate prescribing, theft and diversion. Where the risks of medical cannabis products are no different from those of Sativex, which is in Schedule 4.1, we would suggest putting medical cannabis products into that same Schedule to facilitate patient access. Is this something ACMD could support? Furthermore the CMO’s decision to re-Schedule CBMPs was based on the established clinical value of these products as reviewed in the American National Academy of Sciences report https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state and other data. We believe that her decision should be given equal or greater relevance than a marketing authorisation approval which, in essence, is just a license that allows companies to promote a medicine.
- The current import restrictions impede patient access to medical cannabis in many of the cases we report in the childhood epilepsy paper described above, with predicted dire consequences. This is now particularly evident in patients whose supply from Holland is threatened by Brexit regulations https://www.drugscience.org.uk/too-much-pain/. We would ask the ACMD to review the current approach which is designed to reduce diversion to recreational use by limiting importation, but which in fact damages health more than it protects it. For example, increasing importation quantities to a year’s supply per patient would greatly improve the provision and flow of cannabis medicines. Allowing companies to bring product into the UK without having to first provide clinical need letters from individual doctors would also ease the importation and reduce delay in product supply to UK
- Currently, prescribing is required to be initiated by a specialist. We know from the TWENTY21 data so far, as well as from analyses of international databases, that the majority of patients who benefit from medical cannabis are those with syndromes and symptoms that are cared for by GPs. Surely now it is time to allow those who would like to, to initiate prescribing. This could perhaps be for a limited number of symptoms such as pain (especially to facilitate the desired reduction in chronic use of opiate analgesics) to be allowed to be trained to do this? We know a number of GPs who are interested in doing such training.
- We wondered what the reasoning was behind Epidyolex being in Schedule 5? Given it has no abuse liability there would appear to be no reason to Schedule it, or indeed other cannabidiol products at all.
I look forward to your responses to these comments and again reiterate that Drug Science would be very happy to present on all or any of our medical cannabis research and ideas to the ACMD.
Professor David Nutt FMedSci
Chair – Drug Science Scientific Committee